InsomniaNCT02924116
Bioboosti Device for Insomnia Treatment
A study testing Bioboosti in people with Insomnia, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Bioboosti
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with insomnia
Who cannot join
- Untreated moderate or severe sleep apnea
- Major circadian rhythm disorder
- Pregnant women
- Breastfeeding
- Cardiac pacemaker
- Cancer
Show all 13Show fewer
- Severe conditions related to heart, brain, kidney and hematopoietic system
- Severe/unstable angina pectoris
- Arteria coronaria/ peripheral arterial bypass graft
- Acute congestive heart failure
- Renal insufficiency
- Mechanical intestinal obstruction
- Any electrical devices
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
About this study
Official title: Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment: A Pilot Study
The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.
Read the detailed description
Insomnia is a common health complaint that is associated with discomfort, loss of productivity, poor health and higher use of healthcare. The use of non-pharmacologic treatments for insomnia has gained much attention in recent years. The investigators are conducting this research because a safe, non-pharmacologic treatment would benefit patients with insomnia, and to see if the Bioboosti device is an effective treatment for insomnia.
Subjects will include patients from the clinics who have the diagnosis of insomnia. Study staff will notify the treating physician of a potential subject. If the subject gives permission and would like to obtain more information, study staff will approach them and provide them with the consent form to review. Study staff may also contact them by phone to explain the study and recruit.
Subjects will be asked to make 5 visits:
Visit 1-- consent form, physical exam, vitals, pregnancy test, sleep log
Visit 2-- sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG
Visit 3-- remove EEG, beginning of treatment with Bioboosti device, sleep log Treatment phase-- subjects use the Bioboosti at home for two weeks
Visit 4-- return of Bioboosti, sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG
Visit 5-- remove EEG, collect sleep logs
- Conditions
- Insomnia
- Being tested
- Bioboosti
- Keywords
- insomnia, sleep, Bioboosti, Biomobie, device
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioboostiDevice
Subjects will place the device on the palm of their hand for 8 minutes. There is a light on the device that changes to indicate that the 8 minutes have passed. They will then place it on the palm of the other hand and keep it there for 8 minutes. Alternating 8-minute cycles between hands will be done up to 6 times.
| Study group | Role | What they receive |
|---|---|---|
| Bioboosti | Experimental | Treatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time. Receives: Device: Bioboosti |
| Sustained Efficacy | Experimental | Treatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia.
Subjects will use it once a day for about one hour, before habitual sleep time. Receives: Device: Bioboosti |
| Insomnia and migraine | Experimental | Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time. Receives: Device: Bioboosti |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Change in Insomnia Severity Index (ISI) will be measured. The Insomnia Severity Index (ISI) is a short, 7-item self-report questionnaire used to screen for insomnia, assess its severity, and monitor treatment effectiveness by evaluating sleep problems (like falling/staying asleep, early waking) and their impact on daytime functioning over the past two weeks. Scoring from 0 to 28, with higher scores indicating greater severity, the ISI helps classify insomnia as none, subthreshold, moderate, or severe, guiding clinical decisions in research and practice. This will be done before and after treatment.
Measured: Baseline to 2 weeks
Pittsburgh Sleep Quality Index
The change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 2 weeks will be measured. The PSQI is a widely used, self-rated questionnaire that assesses sleep quality and disturbances over a one-month period. It consists of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), which are summed to yield a global score ranging from 0 to 21. Higher global scores indicate worse sleep quality. Change will be calculated as the PSQI score at 2 weeks minus the PSQI score at baseline (Week 2 - Baseline). Because lower PSQI scores indicate better sleep quality, a negative change score reflects an improvement in sleep quality, whereas a positive change score reflects worsening sleep quality.
Measured: Baseline to 2 weeks
Daytime Sleepiness
Daytime sleepiness will be assessed using a Visual Analog Scale (VAS) from baseline to 2 weeks. The VAS is a subjective measure consisting of a 100 mm horizontal line anchored by "not at all sleepy" (0 mm) on the left and "extremely sleepy" (100 mm) on the right. Participants mark the point on the line that best represents their current level of daytime sleepiness. Higher scores indicate greater sleepiness. Change will be calculated as the VAS score at 2 weeks minus the VAS score at baseline (Week 2 - Baseline). Because higher scores indicate greater sleepiness, a negative change score reflects a reduction in daytime sleepiness (improvement), whereas a positive change score reflects an increase in daytime sleepiness (worsening). The mean change and standard deviation of the change scores will be reported.
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2024
- Study completionApr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects will complete the first arm of the study. Upon completion, the subjects will be offered enrollment into the next long term arm of the study (Sustained Efficacy).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biomobie, Harvard University
- Responsible party
- Principal investigator, Pavlova, Milena,M.D., Brigham and Women's Hospital
- Investigators
- Milena Pavlova, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924116
- Sponsor's protocol ID
- 2016P000996
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2016
- Last updated
- 4 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT02924116
- Acronym / sponsor ID
- 2016P000996
- Conditions
- Insomnia
- Keywords
- insomnia, sleep, Bioboosti, Biomobie, device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Biomobie, Harvard University
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2024 (actual)
- Study completion
- Apr 2025 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 4 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.
Detailed description
Insomnia is a common health complaint that is associated with discomfort, loss of productivity, poor health and higher use of healthcare. The use of non-pharmacologic treatments for insomnia has gained much attention in recent years. The investigators are conducting this research because a safe, non-pharmacologic treatment would benefit patients with insomnia, and to see if the Bioboosti device is an effective treatment for insomnia.
Subjects will include patients from the clinics who have the diagnosis of insomnia. Study staff will notify the treating physician of a potential subject. If the subject gives permission and would like to obtain more information, study staff will approach them and provide them with the consent form to review. Study staff may also contact them by phone to explain the study and recruit.
Subjects will be asked to make 5 visits:
Visit 1-- consent form, physical exam, vitals, pregnancy test, sleep log
Visit 2-- sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG
Visit 3-- remove EEG, beginning of treatment with Bioboosti device, sleep log Treatment phase-- subjects use the Bioboosti at home for two weeks
Visit 4-- return of Bioboosti, sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG
Visit 5-- remove EEG, collect sleep logs
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will complete the first arm of the study. Upon completion, the subjects will be offered enrollment into the next long term arm of the study (Sustained Efficacy).
| Arm | Type | Receives |
|---|---|---|
| Bioboosti | Experimental | Device: BioboostiTreatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time. |
| Sustained Efficacy | Experimental | Device: BioboostiTreatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia. Subjects will use it once a day for about one hour, before habitual sleep time. |
| Insomnia and migraine | Experimental | Device: BioboostiTreatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with insomnia
Key exclusion criteria (13 listed)
- Untreated moderate or severe sleep apnea
- Major circadian rhythm disorder
- Pregnant women
- Breastfeeding
- Cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioboostiSubjects will place the device on the palm of their hand for 8 minutes. There is a light on the device that changes to indicate that the 8 minutes have passed. They will then place it on the palm of the other hand and keep it there for 8 minutes. Alternating 8-minute cycles between hands will be done up to 6 times. | Device | Bioboosti, Insomnia and migraine, Sustained Efficacy |
Primary outcome
Insomnia Severity Index
Time frame: Baseline to 2 weeks
Change in Insomnia Severity Index (ISI) will be measured. The Insomnia Severity Index (ISI) is a short, 7-item self-report questionnaire used to screen for insomnia, assess its severity, and monitor treatment effectiveness by evaluating sleep problems (like falling/staying asleep, early waking) and their impact on daytime functioning over the past two weeks. Scoring from 0 to 28, with higher scores indicating greater severity, the ISI helps classify insomnia as none, subthreshold, moderate, or severe, guiding clinical decisions in research and practice. This will be done before and after treatment.
Pittsburgh Sleep Quality Index
Time frame: Baseline to 2 weeks
The change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 2 weeks will be measured. The PSQI is a widely used, self-rated questionnaire that assesses sleep quality and disturbances over a one-month period. It consists of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), which are summed to yield a global score ranging from 0 to 21. Higher global scores indicate worse sleep quality. Change will be calculated as the PSQI score at 2 weeks minus the PSQI score at baseline (Week 2 - Baseline). Because lower PSQI scores indicate better sleep quality, a negative change score reflects an improvement in sleep quality, whereas a positive change score reflects worsening sleep quality.
Daytime Sleepiness
Time frame: Baseline to 2 weeks
Daytime sleepiness will be assessed using a Visual Analog Scale (VAS) from baseline to 2 weeks. The VAS is a subjective measure consisting of a 100 mm horizontal line anchored by "not at all sleepy" (0 mm) on the left and "extremely sleepy" (100 mm) on the right. Participants mark the point on the line that best represents their current level of daytime sleepiness. Higher scores indicate greater sleepiness. Change will be calculated as the VAS score at 2 weeks minus the VAS score at baseline (Week 2 - Baseline). Because higher scores indicate greater sleepiness, a negative change score reflects a reduction in daytime sleepiness (improvement), whereas a positive change score reflects an increase in daytime sleepiness (worsening). The mean change and standard deviation of the change scores will be reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milena Pavlova, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioboosti in people with Insomnia, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: Baseline to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.